Safety and Preliminary Efficacy of Lipoxin Analog BLXA4-ME Oral Rinse for the Treatment of Gingivitis
Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
Summary
The primary objective is to evaluate the safety of an investigational compound, BLXA4-ME,
topically applied as a daily oral rinse in adults with gingivitis. Safety will be assessed by
the incidence of adverse events, including mucosal inflammation and irritancy and findings
from safety labs. Subjects will be monitored for development of periodontitis, and oral flora
will be analyzed to detect an increase in opportunistic organisms.
The secondary objective is to assess preliminary efficacy of the oral rinse, by monitoring
changes in the plaque index (PI), modified gingival index (MGI), bleeding on probing (BOP)
and levels of interleukin -1β (IL-1β) in gingival crevicular fluid (GCF).
The study comprises three groups in a randomized, placebo-controlled double-blind clinical
trial design. The treatment group (1.0 μM BLXA4-ME oral rinse) and the placebo rinse group
will each include 50 subjects. The no-rinse control group will consist of 25 subjects.
Subjects in the treatment and placebo rinse groups will receive oral rinse (BLXA4-ME or
placebo) to be applied once daily after morning teeth brushing. Safety parameters will be
assessed before and after 3, 7, 14, 21, and 28 days of treatment. Efficacy parameters will be
assessed before and after 14 and 28 days of treatment.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
The Forsyth Institute
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)